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COMPLETED
NCT02750150
PHASE3

Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

Summary

Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.

Official title: A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2013-07-09

Completion Date

2016-04-17

Last Updated

2026-04-22

Healthy Volunteers

No

Interventions

DRUG

Freezed-dried plasma

early transfusion of 4 units of freezed dried plasma

DRUG

Fresh-frozen plasma

Locations (1)

Emergency unit, Salengro hospital,

Lille, France